Infamy in the annals of medical research history

In this issue, Drs Sunder Mehran Khan and Afshan Afshan have penned an insightful and thought-provoking piece on issues around obtaining patient consent in hospitals.

The article discusses the challenges of ensuring doctors receive informed consent, particularly in the face of time constraints, language barriers, and systemic pressures. 

As an example of a comprehensive ethical failure, the authors cite the infamous untreated syphilis study in Tuskegee in the US. Medical history is peppered with cases of dubious and dangerous research and the Tuskegee study is highly deserving of a place in that hall of shame.

The study, which ran from 1932 to 1972, was originally titled ‘The Tuskegee Study of Untreated Syphilis in the Negro Male’ and recruited 600 African American men from Macon County, Alabama. Conducted under the authority of the US Public Health Service, the men were subjected to blood tests, spinal taps, x-rays, and, in many cases, autopsies after death. 

At no point was informed consent sought or obtained from those involved. 

The subjects themselves were completely unaware of the nature of the study and were instead told that they were going to receive treatment for ‘bad blood’ (a catch-all term for any mysterious illness at the time).

In reality, they received no treatment of any kind. Even when penicillin was proven to be a safe and reliable treatment for syphilis, most of the men received no treatment for their syphilis.

According to records, some 399 men were ‘recruited’ because they already had late-latent syphilis, with the remaining 201 men in the control group disease-free at the start of the study. The objective of the experiment was stated as being to test whether syphilis resulted in cardiovascular damage more frequently than neurological damage and also to establish whether the course of syphilis in black men was different to that in white people.

Not only was consent not obtained, the men in the study were not told that they had syphilis, or that it is transmissible through sexual intercourse. Records show that some of the men were given bismuth, mercury, and arsenic, but when no useful data emerged, all treatment was ceased and it was decided to simply follow the men until they died.

The researchers were in direct violation of government legislation that had mandated the treatment of venereal diseases.

A subsequent report by the Assistant Secretary for Health and Scientific Affairs Ad Hoc Advisory Panel stated that “the Macon County Health Department and Tuskegee Institute were cognisant of the study”. Right to the end, penicillin was denied to the men, some 25 years after it became widely available in the 1940s. 

As shocking as it appears today, the study reflected the prevailing racism of its time, particularly in the ‘Deep South’, and the medical establishment played a complicit role. The ideology of so-called ‘scientific racism’, long used to justify slavery and oppression, provided a distorted intellectual framework that allowed such a study to be conceived and carried out. 

The Tuskegee study stands as a stark reminder of the catastrophic consequences of disregarding human dignity and informed consent. It must remain both a warning and a lesson – never to be repeated and never to be forgotten.

A 1974 settlement saw the participants receive a US$10 million lump sum.

In 1997, President Bill Clinton issued a formal apology on behalf of the US government, acknowledging the profound injustice of the research.